Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082498
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2004-05-11
Brief Title:
Safety and Effectiveness of the Oral HIV Entry Inhibitor Vicriviroc in HIV Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Randomized Double-Blind Study of the Safety and Efficacy of Vicriviroc An Orally Administered HIV-1 Entry Inhibitor in HIV-Infected Treatment-Experienced Subjects
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
New treatment options are critical for treatment-experienced HIV infected patients with drug resistance HIV entry inhibitors have been shown effective in patients with resistance to other anti-HIV drugs This study will test the safety and effectiveness of three different doses of vicriviroc formerly known as Schering D SCH-D or SCH 417690 in HIV infected patients
Detailed Description:
Vicriviroc is an oral HIV-1 entry inhibitor that targets the CCR5 receptor of T cells Vicriviroc has been shown safe well-tolerated and active in Phase I clinical trials in treatment-naive HIV infected patients The goal of this study is to evaluate the antiretroviral activity of three dose levels of vicriviroc in HIV infected treatment-experienced patients who are failing their current ritonavir-containing antiretroviral therapy ART
The study will last at least 48 weeks but no more than 5 years There are 3 steps in this study Patients will be randomly assigned to one of 4 groups Group 1 will receive placebo Group 2 will receive 5 mg vicriviroc daily Group 3 will receive 10 mg vicriviroc daily and Group 4 will receive 15 mg vicriviroc daily If at or after Week 16 a participants viral load has not met certain criteria a dose increase of vicriviroc may occur and the participant will enter Step 2 As of 101205 patients in Group 2 and any patients who entered Step 2 following virologic failure in Step 1 will be unblinded and offered either 15 mg vicriviroc daily through this study or the option of seeking alternative treatment All patients will continue their current ART not provided by the study After two weeks patients will receive ART optimized by the results of genotypicphenotypic testing performed at study screening All participants who have received or are receiving vicriviroc will enter Step 3 and be followed for an additional 4 years Participants who complete the study may be eligible to receive vicriviroc through a rollover study sponsored by Schering-Plough the drugs manufacturer
Physical exams and blood collection will occur at study entry Day 4 and Weeks 1 2 4 8 12 16 20 24 32 40 and 48 Additionally blood will be drawn twice at least 2 hours apart at both Weeks 2 and 8 for vicriviroc pharmacokinetic analysis Patients will undergo an electrocardiogram EKG at Weeks 2 8 24 and 48 Patients will be assessed for peripheral neuropathy at study entry and Weeks 24 and 48 and will be asked to complete an adherence questionnaire at entry and Weeks 2 8 16 24 32 40 and 48 For Step 3 participants undergoing follow-up physical exams and blood work will occur every 6 months for 4 years
Five participants currently enrolled at four sites that are no longer receiving funding and who will not be transferred or redirected to a site within their proximity will be subject to the following changes There will no longer be follow-up visits per the schedule of events described in the protocol Instead participants will have their follow-up limited to self-report through telephone interviews to ascertain vital status occurrence of malignancies if any and collection of information such as HIV-1 RNA and CD4 cell count For these participants only the HIV-1 RNA and CD4 cell count will be done as part of the participants clinical care and will not be paid for by the study The follow-up telephone interviews will be conducted at six-month intervals using the script provided by the study team
The study will last at least 48 weeks but no more than 5 years There are 3 steps in this study Patients will be randomly assigned to one of 4 groups Group 1 will receive placebo Group 2 will receive 5 mg vicriviroc daily Group 3 will receive 10 mg vicriviroc daily and Group 4 will receive 15 mg vicriviroc daily If at or after Week 16 a participants viral load has not met certain criteria a dose increase of vicriviroc may occur and the participant will enter Step 2 As of 101205 patients in Group 2 and any patients who entered Step 2 following virologic failure in Step 1 will be unblinded and offered either 15 mg vicriviroc daily through this study or the option of seeking alternative treatment All patients will continue their current ART not provided by the study After two weeks patients will receive ART optimized by the results of genotypicphenotypic testing performed at study screening All participants who have received or are receiving vicriviroc will enter Step 3 and be followed for an additional 4 years Participants who complete the study may be eligible to receive vicriviroc through a rollover study sponsored by Schering-Plough the drugs manufacturer
Physical exams and blood collection will occur at study entry Day 4 and Weeks 1 2 4 8 12 16 20 24 32 40 and 48 Additionally blood will be drawn twice at least 2 hours apart at both Weeks 2 and 8 for vicriviroc pharmacokinetic analysis Patients will undergo an electrocardiogram EKG at Weeks 2 8 24 and 48 Patients will be assessed for peripheral neuropathy at study entry and Weeks 24 and 48 and will be asked to complete an adherence questionnaire at entry and Weeks 2 8 16 24 32 40 and 48 For Step 3 participants undergoing follow-up physical exams and blood work will occur every 6 months for 4 years
Five participants currently enrolled at four sites that are no longer receiving funding and who will not be transferred or redirected to a site within their proximity will be subject to the following changes There will no longer be follow-up visits per the schedule of events described in the protocol Instead participants will have their follow-up limited to self-report through telephone interviews to ascertain vital status occurrence of malignancies if any and collection of information such as HIV-1 RNA and CD4 cell count For these participants only the HIV-1 RNA and CD4 cell count will be done as part of the participants clinical care and will not be paid for by the study The follow-up telephone interviews will be conducted at six-month intervals using the script provided by the study team
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5K24AI051966-03 | NIH | DAIDS ES | httpsreporternihgovquickSearch5K24AI051966-03 |
| 10097 | REGISTRY | None | None |
| ACTG A5211 | None | None | None |